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10/07/2018

Paris, France, July 10th. 2018. Sofinnova Partners, a leading venture capital firm specialized in Life Sciences, today announced that Otsuka Holdings is acquiring its portfolio company ReCor Medical, a medical device company specialized in the treatment of hypertension. The terms of the acquisition are being withheld due to non-disclosure obligations.

ReCor Medical was created in 2009 by Sofinnova Partners, Mano Iyer – who was then entrepreneur-in-residence at Sofinnova Partners and now Chief Operating Officer of ReCor – and Professor Jacques Seguin, MD, who became a large private investor in ReCor. Prof. Seguin was previously founder and CEO of CoreValve, a past Sofinnova portfolio company and a leader in the transcatheter valve replacement space, which was sold to Medtronic. Sofinnova Partners was the sole venture capital investor in ReCor Medical and remained its largest shareholder until the sale to Otsuka.

ReCor Medical is an innovative medical device company that developed the Paradise System, a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions. ReCor recently announced positive results of its landmark RADIANCE-HTN SOLO hypertension study at EuroPCR 2018.

Antoine Papiernik, Managing Partner at Sofinnova Partners and ReCor Board Member, said: “ReCor perfectly illustrates our investment strategy: we worked hand-in-hand with Mano Iyer to create the business vision and plan for ReCor. We then founded and funded the company, and opened our network of experts, key opinion leaders and board members to help grow it. We brought trusted entrepreneurs Jay Watkins as Chairman and Andy Weiss as CEO to help guide and operate the company through to a corporate transaction to our partner Otsuka.”

Jay Watkins, Chairman of ReCor Medical said: “Sofinnova Partners remains one of few VCs willing to fund early-stage med-tech ventures targeting large and important new markets. The firm played a critical role throughout ReCor’s life, and has proven to be a reliable, value-added partner for the company. The field of renal denervation has been a complex one over the last few years with periods of euphoria and periods of doubt. Sofinnova Partners’ support remained constant throughout, helping to build a strong partnership with Otsuka and then navigate through the challenges to a very successful trade sale.”

Mano Iyer, Founder and COO of ReCor Medical added: “ReCor is a success story because Sofinnova Partners, consistent with its philosophy, saw the value of an opportunity which did not yet exist. It had the vision to create and fund the company, not only in the very beginning, but also during the critical early years. Despite the dramatic swings in the field, Sofinnova Partners’ confidence in me and in the management team was essential to keep us motivated when others lost hope. This great exit is therefore particularly sweet.”

Andrew M. Weiss, CEO of ReCor Medical adds: “I came to ReCor thanks to Antoine Papiernik’s introduction to the company. With his help, our team developed the partnership with Otsuka and was able to remain focused on value creation. The recent announcement of our positive RADIANCE-HTN SOLO study results and now the merger with Otsuka demonstrate that our teamwork with Sofinnova Partners was successful. We now have an opportunity to transform the treatment of hypertension and benefit millions of potential patients while providing a solid return for our investors. I look forward to continuing to work to make this technology a possible standard of care in hypertension treatment”.

For more information, please contact:
SOFINNOVA PARTNERS
International: Anne Rein
Tel: +33 6 03 35 92 05
e-mail: anne.rein@strategiesimage.com
United States: Kate Barrette
Tel: +1 212 223 0561
e-mail: kbarrette@rooneyco.com

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together a team of professionals from all over Europe, the US and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a lead or cornerstone investor in seed, start-ups, corporate spin-offs and late stage companies. It has backed nearly 500 companies over more than 45 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.9 billion under management. For more information: www.sofinnova.fr

About ReCor Medical, Inc.
ReCor Medical is a medical device company that designs and manufactures the Paradise System, a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions. The Paradise System is approved for sale in the EU and bears a CE mark, but is not approved for sale in the United States. The System’s intravascular catheters denervate renal nerves by combining the protection of water-based cooling of the renal artery with high intensity ultrasound energy for circumferential renal nerve ablation. The Paradise System has been studied in clinical trials of approximately 300 patients to date. Following the positive outcomes of the RADIANCE-HTN SOLO trial, ReCor will continue its evaluations of Paradise in RADIANCE-HTN TRIO (a feasibility study of patients with resistant hypertension) and REQUIRE (a pivotal study of patients with resistant hypertension in Japan and Korea), and launch the RADIANCE II pivotal study (a study of patients with moderate hypertension) in the United States and Europe.
http://www.recormedical.com/

About Otsuka Holdings Co., Ltd. and Otsuka Medical Devices Co., Ltd.
Otsuka Holdings Co., Ltd. is the holding company of the Otsuka group, a global healthcare group headquartered in Tokyo, Japan. With operations in pharmaceuticals, nutraceuticals, medical devices and other health-related businesses, the group generated worldwide sales of JPY1,240 billion in the fiscal year ended December 2017.
http://www.otsuka.com/en/

Established in 2011, Otsuka Medical Devices Co., Ltd. is a fully-owned subsidiary of Otsuka Holdings and one of its core operating subsidiaries. Otsuka Medical Devices focuses on the development and commercialization of endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment.
Otsuka Medical Devices conducts the REQUIRE trial for renal denervation in hypertensive patients (n=140), who are uncontrolled on 3 or more medications including a diuretic, in Japan and Korea through its subsidiary JIMRO Co., Ltd.
http://www.omd.otsuka.com/en/

26/03/2015

• L’opération a été 3,8 fois sursouscrite, notamment par les investisseurs institutionnels internationaux
• La capitalisation boursière de Cerenis atteint 226 M€

Paris, France – 26 mars 2015. Sofinnova Partners, société de capital-risque dans les sciences de la vie basée à Paris, annonce le succès de l’introduction en bourse Cerenis Therapeutics qui a levé 53,4 M€ sur le compartiment B du marché règlementé d’Euronext à Paris (« Euronext Paris »). Sofinnova Partners était le principal actionnaire de la société depuis sa création en 2005. L’opération en bourse a été 3,8 fois sursouscrite, en particulier par les investisseurs institutionnels internationaux.

Basée à Toulouse, Cerenis Therapeutics est une société biopharmaceutique internationale dédiée à la découverte et au développement de thérapies nouvelles HDL pour le traitement des maladies cardio-vasculaires et métaboliques. Cerenis développe des mimétiques des HDL pour induire la régression rapide de la plaque d’athérome chez les patients à risque, et des molécules élevant la concentration des HDL chez les patients déficients.

Denis Lucquin, partenaire-associé chez Sofinnova Partners et membre du Conseil d’administration de Cerenis Therapeutics depuis 2005, déclare : « Cerenis a réalisé une des plus belles introductions en bourse en France depuis de nombreuses années. En tant qu’investisseur historique et toujours premier actionnaire de la société après cette opération, nous sommes particulièrement satisfaits de la qualité du tour de table ainsi constitué. Ce succès atteste de la qualité de la collaboration établie depuis l’origine de la société, avec le Dr Jean Louis Dasseux, Fondateur et Directeur Général. Le rôle du Dr Richard Pasternak, Président non exécutif, fut également déterminant ».

Au total, le nombre d’actions émises s’établit à 4 207 316, permettant la réalisation d’une augmentation de capital de 53,4 M€. Sur la base d’un total de 17 788 878 actions à admettre aux négociations et d’un prix par action de 12,70 €, la capitalisation boursière de Cerenis Therapeutics s’élève à 226 M€ à l’issue de l’opération. Les actions seront négociées sur Euronext Paris sous le code ISIN FR0012616852 et le mnémonique CEREN à compter du 30 mars 2015. Se référer au communiqué de la société (www.cerenis.com) pour de amples informations sur l’opération.
A propos de Sofinnova Partners
Sofinnova Partners est une société de capital-risque indépendante basée à Paris. Depuis 40 ans, la société a financé près de 500 sociétés – start-up, spin-off et opérations de retournement. Elle a accompagné les plus grands entrepreneurs européens dans le domaine des sciences de la vie. Avec 1,3 milliard d’euros sous gestion, l’équipe de Sofinnova Partners, reconnue pour sa capacité à aider et à soutenir les entreprises de son portefeuille de la création à la sortie, a permis l’émergence de leaders sur leurs marchés. Tournée vers l’international, la société investit à travers l’Europe à partir de son bureau parisien, et sa société sœur Sofinnova Ventures se situe à Palo Alto.
www.sofinnova.fr

26/03/2015

Très forte demande : 153 M€ (offre sursouscrite 3,8 fois)
– Prix fixé en haut de fourchette à 12,70 € par action
– Capitalisation boursière de 226 M€

Toulouse, FRANCE, Ann Arbor, ETATS-UNIS, 25 mars 2015 – Cerenis Therapeutics, société biopharmaceutique internationale dédiée à la découverte et au développement de nouvelles thérapies HDL (bon cholestérol) pour le traitement des maladies cardio-vasculaires et métaboliques, annonce aujourd’hui le succès de son introduction en bourse sur le compartiment B du marché règlementé d’Euronext à Paris (« Euronext Paris »), en levant 53,4 M€ par voie d’augmentation de capital.

Le placement global et l’offre au public ont rencontré un très large succès soulignant l’engouement de la part d’un très grand nombre d’investisseurs institutionnels, tant français qu’internationaux, et des investisseurs particuliers :
 Placement global : demande de souscription totale de 120 M€
 Offre à prix ouvert : demande de 33 M€.

Au regard de la forte demande globale constatée, soit 153 M€ (offre sursouscrite 3,8 fois), le Conseil d’Administration réuni ce jour a décidé la mise en œuvre intégrale de la Clause d’Extension et constaté l’exercice intégral de l’Option de Surallocation par les Chefs de File et Teneurs de Livre Associé. Il a par ailleurs décidé de fixer le Prix de l’Offre à 12,70 € par action, en haut de la fourchette indicative de prix.

Au total, le nombre d’actions émises s’établit à 4 207 316, permettant la réalisation d’une augmentation de capital de 53,4 M€. Sur la base d’un total de 17 788 878 actions à admettre aux négociations et d’un prix par action de 12,70 €, la capitalisation boursière de Cerenis Therapeutics s’élève à 226 M€ à l’issue de l’opération.
Les actions offertes dans le cadre de l’offre globale seront allouées de la manière suivante :
 Placement global : 3 786 584 actions allouées aux investisseurs institutionnels (représentant 48,1 M€ et 90% du nombre total des actions allouées) ;
 Offre à prix ouvert : 420 732 actions allouées au public (représentant 5,3 M€ et 10% du nombre total des actions allouées) ;
 Dans le cadre de l’OPO, les ordres A1 seront servis à hauteur de 28% et les ordres A2 ne seront pas servis.

Le règlement livraison des actions émises au titre de l’offre à prix ouvert et du placement global interviendra le 27 mars 2015. Les actions seront négociées sur Euronext Paris sous le code ISIN FR0012616852 et le mnémonique CEREN. Un contrat de liquidité conclu avec la société de bourse Gilbert Dupont sera mis en œuvre dès l’ouverture des négociations le 30 mars 2015.
Jean-Louis Dasseux, Fondateur et Directeur Général de Cerenis Therapeutics déclare : « Nous sommes très heureux d’annoncer le spectaculaire succès de l’introduction en bourse de Cerenis Therapeutics, et tenons à remercier tout particulièrement nos actionnaires historiques ainsi que les nouveaux investisseurs, institutionnels et particuliers, pour leur confiance dans notre solution de rupture en HDL thérapie. Nous adressons également nos remerciements à l’ensemble des collaborateurs de la Société dont les efforts soutenus ont contribué au succès de cette opération. Désormais dotés des moyens financiers nécessaires au déploiement de notre stratégie clinique, nous réaffirmons, plus que jamais, notre confiance dans le potentiel de création de valeur à court terme de CER-001 dont les deux indications visées permettront d’adresser un vaste marché de près de 3 millions de patients. Les fonds levés seront ainsi principalement alloués au financement de deux études, dès 2015 : une phase II dans l’indication « post syn rome coronarien aigu » et une phase III dans l’indication « déficients génétiques en HDL », cette dernière étude devant conduire à un dépôt de dossier d’Autorisation de Mise sur le Marché (AMM) avant 2018. »

▪ Rappel des objectifs de la levée de fonds
– Financer l’ensemble des coûts de l’étude de phase II sur l’indication post-SCA (CARAT) dont les résultats devraient être disponibles au premier trimestre 2017, en ce compris les coûts de fabrication du produit testé ;
– Financer l’ensemble des coûts de l’étude de phase III sur l’indication de maladie orpheline FPHA (TANGO), en ce compris les coûts de fabrication du produit testé. Cette étude de phase III soutiendra l’autorisation de mise sur le marché du CER-001 à horizon 2018 pour traiter les patients atteints de FPHA définie génétiquement ;
– Financer l’activité courante de la Société.

▪ Calendrier de l’opération – prochaines échéances
 27 mars 2015
 Règlement-livraison de l’OPO et du Placement Global
 30 mars 2015
 Début des négociations des actions de la Société sur Euronext Paris

▪ Codes d’identification des titres Cerenis
– Libellé : CERENIS
– Code ISIN : FR0012616852
– Mnémonique : CEREN
– Compartiment : Compartiment B
– Secteur d’activité :
o Code NAF : 7211Z – Recherche – développement en biotechnologie
o Classification ICB : 4573 – Biotechnology

▪ Intermédiaires financiers
Chefs de File et Teneurs de Livre Associés
Mise à disposition du prospectus – Des exemplaires du prospectus (le « Prospectus »), visé le 11 mars 2015 sous le numéro 15-085 par l’Autorité des marchés financiers (l’ « AMF »), constitué d’un document de base enregistré par l’AMF le 3 mars 2015 sous le numéro l.15-009 (le « Document de base ») et d’une note d’opération (la « Note d’Opération ») contenant le résumé du Prospectus, sont disponibles sans frais et sur simple demande auprès de Cerenis (265 rue de la Découverte, 31670 Labège, France) ainsi que sur les sites Internet de la Société (www.cerenis.com) et de l’AMF (www.amf-france.org).

Facteurs de risques – Cerenis attire l’attention du public sur les risques relatifs à l’activité décrits au chapitre 4 «Facteurs de risques» du Document de Base et les risques liés à l’offre décrits au chapitre 2 «Facteurs de risques liés à l’offre» de la Note d’Opération.

A propos de Cerenis : www.cerenis.com
Cerenis Therapeutics Holding est une société biopharmaceutique internationale dédiée à la découverte et au développement de thérapies nouvelles HDL pourle traitement des maladies cardio-vasculaires et métaboliques. Cerenis développe des mimétiques des HDL pourinduire la régression rapide de la plaque d’athérome chez les patients à risque, et des molécules élevant la concentration des HDL chez les patients déficients. Cerenis est bien positionnée pour devenir un des leaders du marché des thérapies HDL avec un large portefeuille de produits en développement et un actionnariat prestigieux : Sofinnova Partners, HealthCap, Alta Partners, EDF Ventures, DAIWA Corporate Investment, TVM Capital, Orbimed, IRDI/IXO Private Equity et Bpifrance.

A propos du CER-001
CER-001 est un complexe comprenant la protéine naturelle des HDL, l’apolipoprotéine A-I (apoA-I), et des phospholipides, dont la composition a été optimisée afin d’obtenir une nanoparticule discoïdale chargée négativement ressemblant à une particule pré-bêta HDL naturelle. CER-001 agit sur toutes les étapes du transport retour du cholestérol comme le ferait une HDL naturelle afin de promouvoir l’élimination du cholestérol.

Cerenis
Jean-Louis Dasseux
Directeur Général
info@cerenis.com
Tel: +33 (0)5 62 24 09 49

NewCap
Relations investisseurs
Emmanuel Huynh / Louis-Victor Delouvrier
cerenis@newcap.fr
01 44 71 98 53
NewCap

Relations Médias
Nicolas Merigeau
cerenis@newcap.fr
01 44 71 94 98
Avertissement
Aucune communication ni aucune information relative à l’émission par Cerenis des actions ne peut être diffusée au public dans un pays dans lequel une obligation d’enregistrement ou d’approbation est requise. Aucune offre d’actions n’estfaite, ni ne sera faite en France, préalablement à l’obtention d’un visa de l’Autorité des marchés financiers (l’ «AMF ») sur un prospectus composé du document de base, objet de ce communiqué, et d’une note d’opération qui sera soumise ultérieurement à l’AMF. Aucune démarche n’a été entreprise ni ne sera entreprise en dehors de France, dans un quelconque pays dans lequel de telles démarches seraient requises. L’émission ou la souscription des actions peuvent faire l’objet dans certains pays de restrictions légales ou réglementaires spécifiques. Cerenis n’assume aucune responsabilité au titre d’une violation par une quelconque personne de ces restrictions.
Le présent communiqué, et les informations qu’il contient, ne constitue pas et ne saurait être considéré comme constituant une offre au public, une offre d’achat ou comme destiné à solliciter l’intérêt du public en vue d’une opération par offre au public. La diffusion de ce communiqué peut, dans certains pays, faire l’objet d’une réglementation spécifique. Les personnes en possession du présent document doivent s’informer des éventuelles restrictions locales et s’y conformer.
Ce communiqué ne doit pas être distribué, directement ou indirectement, aux Etats-Unis. Ce communiqué ne constitue pas une offre de valeurs mobilières ou une quelconque sollicitation d’achat de valeurs mobilières aux Etats-Unis ni dans toute autre juridiction dans laquelle telle offre ou sollicitation pourrait faire l’objet de restrictions. Des valeurs mobilières ne peuvent être offertes ou vendues aux Etats-Unis qu’à la suite d’un enregistrement en vertu du U.S. Securities Act de 1933, tel que modifié, ou dans le cadre d’une exemption à cette obligation d’enregistrement. Les actions de Cerenis n’ont pas été et ne seront pas enregistrées au titre du U.S. Securities Act de 1933, tel que modifié, et Cerenis n’a pas l’intention de procéder à une offre au public de ses valeurs mobilières aux Etats-Unis.
Le présent communiqué constitue une communication à caractère promotionnel et non pas un prospectus au sens de la Directive Prospectus (telle que définie ci-dessous), telle que transposée dans chacun des Etats membres de l’Espace Economique Européen.
S’agissant des Etats membres de l’Espace Economique Européen ayant transposé la Directive Prospectus (chacun un « Etat Membre Concerné »), aucune action n’a été entreprise et ne sera entreprise à l’effet de permettre une offre au public des valeurs mobilières objet de ce communiqué rendant nécessaire la publication d’un prospectus dans un Etat Membre Concerné (autre que la France). En conséquence, les actions de Cerenis ne peuvent être offertes et ne seront offertes dans aucun des Etats Membres Concerné (autre que la France), sauf conformément aux dérogations prévues par l’article 3 de la Directive Prospectus, si elles ont été transposées dans cet Etat Membre Concerné ou dans les autres cas ne nécessitant pas la publication par la Société d’un prospectus au titre de l’article 3(2) de la Directive Prospectus et/ou desrèglementations applicables dans cet Etat Membre Concerné.
Pour les besoins du présent avertissement, l’expression « offre au public » en liaison avec toute action de Cerenis dans tout Etat Membre Concerné signifie la communication, sous quelque forme et par quelque moyen que ce soit, d’informations suffisantes sur les conditions de l’offre et sur les actions à offrir, de manière à mettre un investisseur en mesure de décider d’acheter ou de souscrire aux valeurs mobilières, telles qu’éventuellement modifiées par l’Etat Membre Concerné par toute mesure de transposition de la Directive Prospectus dans cet Etat Membre. L’expression « Directive Prospectus » signifie la Directive 2003/71/EC (telle que modifiée, y compris par la Directive 2010/73/EU), et comprend toute mesure pertinente de transposition dans l’Etat Membre Concerné.
En ce qui concerne le Royaume-Uni, ce communiqué est destiné et adressé uniquement aux personnes qui (i) ont une expérience professionnelle en matière d’investissements (« investment professionals ») visées à l’article 19(5) du Financial Services and Markets Act 2000 (Financial Promotion Order) 2005, tel que modifié (l’ « Ordre »), (ii) sont visées à l’article 49(2)(a) à (d) de l’Ordre (« high net worth companies, unincorporated associations etc. ») ou (iii) sont des personnes auxquelles le présent communiqué peut être légalement communiqué (toutes ces personnes mentionnées en (i), (ii), et (iii) étant ensemble dénommées les « Personnes Qualifiées »). Ce communiqué ne doit pas être utilisé au Royaume-Uni par des personnes qui ne seraient pas des Personnes Qualifiées. Tout investissement lié à ce document ne pourra être proposé ou conclu au Royaume-Uni qu’avec des Personnes Qualifiées.

Le présent communiqué contient des déclarations prospectives. Aucune garantie ne peut être donnée quant à la réalisation de ces déclarations prospectives qui sont soumises à des risques tels que, notamment, ceux décrits dans le document de base de la Société enregistré auprès de l’Autorité des marchés financiers sous le numéro I. 15-009 le 3 mars 2015, et à l’évolution de la conjoncture économique, des marchés financiers et des marchés sur lesquels CERENIS est présente.

19/03/2015

Zug, Switzerland, March 19, 2015 – Auris Medical Holding AG (NASDAQ: EARS) today provided an update on the Company’s business and announced financial results for the fourth quarter and financial year ended De-cember 31, 2014.

« We achieved significant progress during 2014 in advancing our on-going drug development programs, while also meeting the low-end of our full-year operating expenses guidance, » commented Thomas Meyer, the Com-pany’s founder, Chairman and CEO. « 2015 has started well for Auris Medical, with positive results from the in-terim analysis of one of our AM-101 trials. Our investigational tinnitus treatment was tested for the first time beyond the acute stage, and showed activity also there, especially in the earlier post-acute phase. This outcome lends further support to our strategy of targeting tinnitus at the periphery of the auditory system and could lead to a significantly broader indication for AM-101.”

Recent Business Highlights
• The AM-101 Phase 3 clinical program in acute inner ear tinnitus continued to progress and remains on track. In early March, more than one third of the target patient number for the TACTT2 trial (primarily con-ducted in North America), and more than 40% of the target for the TACTT3 trial (conducted in Europe), had been enrolled.
• The interim efficacy analysis in the exploratory post-acute tinnitus stratum of the TACTT3 trial (i.e. tinnitus onset between 3 and 12 months; “Stratum B”) showed positive results. The analysis showed activity of AM-101 beyond the core target indication of acute inner ear tinnitus (i.e. up to 3 months from onset). Based on recommendations from the Independent Data Review Committee, the inclusion criteria were adapted in or-der to focus on the early post-acute stage where higher levels of activity were observed compared to the later stage. Accordingly, Stratum B will continue to enroll patients with tinnitus onset between 3 and 6 months prior, and halt enrollment of patients with onset 6 to 12 months prior to enrollment. The TACTT2 trial and Stratum A of TACTT3, which enroll patients with tinnitus up to 3 months from onset and were not part of the interim analysis, will continue unchanged.
• The important unmet medical need in tinnitus care was highlighted at a recent educational event for inves-tors sponsored by Auris Medical in New York City. Michael D. Seidman, MD, Director Otologic/Neurotologic Surgery Henry Ford Health System, Detroit, described the lack of effective and satisfactory treatment and management options currently available for tinnitus patients. This was reiterated by the account of a pa-tient who described the burden of her tinnitus and her many unsuccessful attempts to find relief. Dr Seidman stated that he considers AM-101’s mechanism of action to be more attractive in treating tinnitus than other current approaches and noted that AM-101, subject to positive outcomes from the Phase 3 tri-als, could become the first approved drug for the treatment of tinnitus.
• Auris Medical’s intellectual property portfolio has been expanded through the recent issuance of patents by the Chinese and Indian patent offices which cover the use of AM-101 in the treatment of tinnitus. AM-101 now benefits from extensive patent coverage in more than 40 jurisdictions worldwide, including major countries, such as the US, Europe, Japan, China, India, and Russia.
• The FDA opened an Investigational New Drug application (IND) for AM-111 for the treatment of acute sensorineural hearing loss (ASNHL). Under the IND, the Company intends to conduct a randomized, place-bo-controlled, double-blind Phase 2/3 trial in the US to assess AM-111’s efficacy and safety in the treat-ment of surgery-induced hearing loss following cochlear implantation. In a pre-clinical model of cochlear implant surgery trauma, local application of AM-111 30 minutes prior to cochlear electrode insertion pro-vided a significant level of protection against surgery-induced hearing loss, loss of hair cells and damage to neural elements.1 Treatment with AM-111, therefore, could allow for effective hearing preservation and protection of at-risk cochlear sensory structures during the process of cochlear implantation, which is a key objective in patients who still maintain residual hearing. In the planned REACH trial, Auris Medical will test a single intraoperative dose of AM-111 0.4 mg/mL. in patients undergoing cochlear implant surgery.
• Preparations for our planned pivotal HEALOS trial with AM-111 in Europe and Asia continue to progress towards an expected initiation in around mid-2015. Following the FDA’s feedback from the Pre-IND meet-ing for HEALOS, we expect to complete the regulatory consultation process with additional input from the European Medicines Agency (EMA) shortly.

Financial Results
As of December 31, 2014, the Company had CHF 56.9 million in cash and cash equivalents. Operating expenses for the three months ended December 31, 2014 were CHF 5.6 million, with CHF 4.7 million attributable to re-search and development. This compares to operating expenses of CHF 3.3 million and research and development expenses of CHF 2.9 million for the same period in 2013. The Company reported a net loss for the quarter ended December 31, 2014 of CHF 3.9 million, or CHF 0.17 per share. This compares to a net loss of CHF 3.5 million, or CHF 0.24 per share, for the same period in 2013.
For the twelve month period ended December 31, 2014, operating expenses were CHF 22.2 million, with CHF 17.7 million attributable to research and development. This is in line with previous guidance and compares to operating expenses of CHF 14.6 million and research and development expenses of CHF 13.3 million for the same period in 2013. The Company reported a net loss for the twelve months ended December 31, 2014 of CHF 18.2 million, or CHF 0.66 per share. This compares to a net loss of CHF 15.0 million, or CHF 1.01 per share, for the same period in 2013.
The increases in operating expenses, and resulting increases in operating loss, for the three- and twelve-month periods ended December 31, 2014 over the comparable periods in 2013 reflect primarily the progression of the AM-101 Phase 3 clinical development program, preparations for the late stage AM-111 clinical program, head-count expansion, and higher legal and auditing expenses related to the IPO. On the other hand the Company benefited from substantial realized and unrealized gains on foreign currency positions, especially those held in US Dollars.
1 Eshraghi AA, Gupta C, Van De Water TR, Bohorquez JE, Garnham C, Bas E, Talamo VM (2013): Molecular mechanisms involved in cochlear implantation trauma and the protection of hearing and auditory sensory cells by inhibition of c-Jun-N-terminal kinase signaling, Laryngoscope 123 (Suppl 1), S1-S14.

The Company expects the operating expenses for the 2015 financial year to be in the range of CHF 25.0 to 30.0 million. This outlook is based on management’s current expectations and beliefs.
Annual Report and Annual General Meeting of shareholders
The Annual General Meeting of shareholders of Auris Medical Holding AG will be held on April 22, 2015, in Zug, Switzerland. The agenda, as well as the Company’s Annual Report and Form 20-F, will be published on March 30, 2015.

Conference Call / Webcast Information
Auris Medical will host a live conference call and webcast to discuss the Company’s financial results and provide a general business update. The call is scheduled for March 19, 2015 at 8:00 a.m. Eastern Time (1:00 p.m. Central European Time). To participate in this conference call, dial 1 855 217 7942 (USA) or +1 646 254 3372 (Interna-tional), and enter passcode 5873195. A live, listen-only audio webcast of the conference call can be accessed on the Investor Relations section of the Auris Medical website at: www.aurismedical.com. A replay will be available approximately two hours following the live call also on the Company’s website.

About Auris Medical
Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address im-portant unmet medical needs in otolaryngology. The Company is currently focusing on the development of treatments for acute inner ear tinnitus (AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic injection with biocompatible gel formulations. In addition, Auris Medical is pursuing early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzer-land. The shares of the parent company Auris Medical Holding AG trade on the NASDAQ Global Market under the symbol « EARS ».

Forward-looking Statements
This press release may contain statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or Auris Medical’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other compa-rable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the timing and conduct of clinical trials of Auris Medical’s product candidates, the clinical utility of Auris Medical’s product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical’s intellectual property position and Auris Medical’s financial position, including the impact of any future acquisi-tions, dispositions, partnerships, license transactions or changes to Auris Medical’s capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption “Risk Factors” in Auris Medical’s prospectus relating to its Registration Statement on Form F-1, as amended, and future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

Contact: Dr. Thomas Meyer, Chairman and CEO, +41 41 729 71 94, ear@aurismedical.com
Investors: Matthew P. Duffy, Managing Director, LifeSci Advisors, 212-915-0685, matthew@lifesciadvisors.com

Auris Medical Q4 2014 Earnings Release 2015-03-19

11/03/2015

Zug, Switzerland, March 10, 2015 – Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage compa-ny dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced the completion of the planned interim analysis in the post-acute tinnitus stratum of the TACTT3 trial (“Stratum B”) with AM-101 and that enrollment could continue since the pre-specified futility threshold was not reached. Based on recommendations by the Independent Data Review Committee, the inclusion criteria will be adapted in order to focus on the early post-acute stage where higher levels of ac-tivity were observed than at the later stage. Accordingly, Stratum B will continue to enroll patients with tinnitus having started between 3 and 6 months prior and stop enrollment of patients with onset 6 to 12 months prior. The TACTT2 trial and Stratum A of TACTT3, which enroll patients with tinnitus up to 3 months from onset and were not part of the interim analysis, will continue unchanged.

The interim analysis on Stratum B of the randomized, double-blind, placebo-controlled European TACTT3 trial was performed based on 150 study participants (50% of the planned total) completing their second follow-up visit on Day 35. Futility was assessed since AM-101 had never before been tested beyond the acute stage of tinnitus (up to 3 months from onset). The evaluation was based on the primary efficacy vari-able of the trial, improvement in subjective tinnitus loudness, as well as on improvement in the Tinnitus Functional Index.
“We are very encouraged about the positive outcome from the interim analysis and look forward to con-tinuing Stratum B to explore AM-101’s therapeutic benefits in the post-acute stage”, commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. He added: “The outcome lends further support to our approach of treating inner ear tinnitus early, while the symptom is still of peripheral rather than central character.” Bettina Stubinski, Chief Medical Officer of Auris Medical, stated: “Although accumulating evi-dence points to the benefits of early treatment, therapeutic benefits may still be possible to achieve even at later stages. The full analysis of outcomes from Stratum B will provide us with important further insights into the therapeutic time window for AM-101 and the natural history of inner ear tinnitus.“

About acute inner ear tinnitus
Tinnitus, the perception of sound without external acoustic stimulation, is a symptom common to various ear or other diseases. (Inner ear tinnitus may be provoked by various injuries to the cochlea, the organ of hearing, such as overexposure to noise or inflammation. It may be short and just transitory; however, it may also become permanent. Tinnitus of less than three months of duration is considered acute, while older tinnitus is considered chronic.
Inner ear tinnitus may be only a slight nuisance, but often it has a serious impact on the ability to sleep, relax, or concentrate, or it may lead to tiredness, irritation, nervousness, despair, frustration, or even depres-sion. As of today, there exists neither a universal standard of care for acute inner ear tinnitus, nor a truly proven, effective treatment method. Auris Medical Holding AG • Bahnhofstrasse 21 • CH-6300 Zug • Tel. +41 41 729 71 94 • www.aurismedical.com

About AM-101
AM-101 is a small molecule N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a biocompat-ible gel for intratympanic injection. Emerging evidence suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following inner ear excitotoxicity, which is characterized by exces-sive synaptic release of glutamate, the principal neurotransmitter in the auditory system. Cochlear excitotoxicity may be triggered by, for example, exposure to excessive noise, neuroinflammation, disturb-ances in inner ear blood supply (anoxia/ischemia), or the administration of certain ototoxic drugs. It has been proposed that the upregulation of NMDA receptors induced by cochlear excitotoxicity is responsible for aberrant excitation of auditory nerve fibers, which is perceived as tinnitus.
The development of AM-101 is based on research conducted at the INSERM Institute for Neurosciences of Montpellier, France. The clinical development of AM-101 was initiated by Auris Medical in 2007 and com-prises three completed clinical trials to date. Currently, two pivotal trials with AM-101 are ongoing in North America and Europe (TACTT2 and TACTT3). In 2013, Auris Medical reached agreement with the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its pivotal TACTT2 study. Patents have been granted in more than 40 countries worldwide so far.

About Auris Medical
Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology. The Company is currently focusing on the development of treatments for acute inner ear tinnitus (AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic injection with biocompatible gel formulations. In addition, Auris Medical is pursuing early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of Auris Medical Holding AG trade on the NASDAQ Global Market under the symbol « EARS ».

Forward-looking Statements
This press release may contain statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or Auris Medical’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expecta-tions and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the timing and conduct of clinical trials of Auris Medical’s prod-uct candidates, the clinical utility of Auris Medical’s product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical’s intellectual property position and Auris Medical’s financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical’s capital structure, including future securities offerings. These risks and uncertainties also in-clude, but are not limited to, those described under the caption “Risk Factors” in Auris Medical’s prospectus relating to its Registration Statement on Form F-1, as amended, and future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and Auris Medi-cal does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.
Contact: Dr. Thomas Meyer, Chairman and CEO, +41 41 729 71 94, ear@aurismedical.com

27/02/2015

Paris, 26 février 2015, 7h30 – Le Conseil d’administration de Pixium Vision (FR0011950641 – PIX), présidé par Bernard Gilly, s’est réuni le 25 février 2015 pour arrêter les comptes de l’année 2014 publiés aujourd’hui. Les comptes de l’année 2014 ont été audités par les Commissaires aux Comptes.

Khalid Ishaque, Directeur Général de Pixium Vision, déclare : « L’année 2014 a marqué l’accélération de la transformation de Pixium Vision. Au-delà de ses efforts continus de R&D, la société a réussi deux projets stratégiques pour son avenir : son introduction en bourse et sa certification ISO 13485. » Khalid Ishaque a ajouté : « En tout juste 3 ans d’existence, la société a réalisé des avancées considérables. Pixium Vision a racheté et développé les actifs d’IMI. IRIS50 est entré en étude clinique et IRIS150 a été conçu, fabriqué et est actuellement en cours de test de vieillissement accéléré. D’autre part, Pixium Vision a signé un accord de licence avec l’université de Stanford pour PRIMA, son produit de deuxième génération. Le transfert de technologie est en cours d’achèvement et les implants PRIMA vont débuter une série de tests précliniques pour une première implantation dans l’homme à la fin de 2016. Enfin, la Société a récemment annoncé jusqu’à 6,9 millions d’euros de nouveaux financements pour PRIMA dans le cadre du projet SIGHT AGAIN.»

 

Résultats de l’année 2014

Synthèse du compte de résultat
En milliers d’euros 2014 2013
Produits opérationnels 2 426,6 1 478, 2
Recherche et Développement (10 963,0) (6 590,0)
Frais Généraux (3 111,4) (1 034,9)
Résultat opérationnel (11 647,8) (6 146,6)
Résultat net (11 611,3) (6 145,8)
Résultat par action (1 ,18)€ (0,22)€

 

Synthèse du tableau de flux de trésorerie
En milliers d’euros 2014 2013
Trésorerie, équivalents de trésorerie à l’ouverture 9 420,2 3 088,6
(Diminution) / Augmentation de la trésorerie 32 711,5 6 331,6
dont flux de trésorerie net lié aux activités opérationnelles (8 389,5) (5 187,4)
Trésorerie, équivalents de trésorerie à la clôture 42 131,7 9 420,2

 

 

Les produits opérationnels  se sont élevés respectivement à 1 478 219 euros et 2 426 576 euros en 2013 et 2014. Ces montants comprennent le Crédit Impôt Recherche (CIR) (respectivement
1 478 219 euros et 2 004 974 euros pour les exercices 2013 et 2014), et une subvention liée au projet SIGHT AGAIN d’un montant de 421 551 euros en 2014. La hausse du CIR entre 2013 et 2014 est liée à l’augmentation des dépenses de R&D en 2014 avec en particulier les développements clinique, préclinique et réglementaire d’IRIS50® et d’IRIS150® ainsi que le développement industriel de PRIMA.

En 2014, le montant total des dépenses de recherche et développement (R&D) s’est établit à 10 962 963 euros contre 6 589 960euros un an plus tôt. Ces efforts, en ligne avec plan de développement de la société, portent principalement sur les dépenses de sous-traitance, collaboration et consultants liées au développement clinique, préclinique et réglementaire d’IRIS50® et d’IRIS150® ainsi qu’au développement industriel de PRIMA. L’augmentation des dépenses de R&D est aussi liée au renforcement de l’équipe qui passe de 20 à 26 employés sur la période

En 2014, les frais généraux se sont élevés à 3 111 421 euros contre 1 034 846 euros un an auparavant. Cette hausse s’explique principalement par la comptabilisation d’une charge non cash de 837 287 euros au titre des retraitements IFRS2 liée à l’attribution d’actions gratuites. Par ailleurs, la société a provisionné  une contribution patronale sur les actions gratuites à hauteur de  247  830 euros. Enfin, l’augmentation d’une année sur l’autre des frais généraux est aussi liée au renforcement de l’équipe de direction ainsi qu’aux frais engendrés par le statut d’entreprise cotée en bourse (avocats, audit, consultants).

En conséquence, la perte nette s’est élevée respectivement à 6 145 814 euros et 11 611 283 euros au titre des exercices 2013 et 2014. La perte par action émise (nombre moyen pondéré d’actions en circulation au cours de l’exercice) s’est élevée respectivement à 0,22 euro et 1,18 euro en 2013 et 2014.

La consommation de trésorerie liée aux activités opérationnelles en 2013 et 2014 s’est élevée respectivement à 5 187 445 euros et 8 389 532 euros. Cette augmentation s’explique notamment par les efforts soutenus de R&D avec les développements clinique, préclinique et réglementaire d’IRIS50® et d’IRIS150® et développement industriel de PRIMA) et par le développement de la société avec l’augmentation du nombre de salariés et des achats de fournitures.

Les flux nets de trésorerie liés aux activités de financement se sont élevés à 42,9 millions d’euros en 2014 contre 11,8 millions d’euros un an auparavant reflétant notamment le succès de l’introduction en bourse sur Euronext de la société en juin dernier.La trésorerie nette au 31 décembre 2014 s’est élevé à 42,1 millions d’euros contre 9,4 millions d’euros un an auparavant.

 

 

Contacts

 

Pixium VisionPierre Kemula, CFO

contact@pixium-vision.com

+33 1 76 21 47 30

Relations Investisseurs / Relations PresseCitigate Dewe Rogerson

Lucie Larguier – Laurence Bault (Paris)

pixium-vision@citigate.fr

+33 1 53 32 84 78

 

Relations Presse Hors investisseurs

NewcapMedia

Annie-Florence Loyer – Nadège Le Lezec

afloyer@newcap.fr /nlelezec@newcap.fr

 

 

A propos de Pixium Vision (www.pixium-vision.com)

Pixium Vision développe des systèmes de restauration de la vision (SRV) innovants pour permettre aux personnes ayant perdu la vue de vivre de façon plus autonome. Les SRV de Pixium Vision sont des systèmes composés de plusieurs éléments de haute technologie associés à une intervention chirurgicale et à une période de rééducation. Ils visent à offrir à terme aux patients une vision aussi proche que possible de la normale.

Le SRV IRIS® est actuellement en phase d’essais cliniques dans plusieurs centres en Europe.Les patients supportent bien leur implant à ce jour et des améliorations de la perception visuelle des patients aveugles sont observées. Les résultats de ces études seront utilisés pour déposer une demande de marquage CE. Sous réserve d’obtention du marquage CE, la commercialisation d’IRIS devrait débuter en 2015.

Pixium Vision développe également PRIMA, un implant sous-rétinien, qui est actuellement à un stade préclinique. La société envisage de commencer les essais cliniques de PRIMA en Europe en 2016.

La société est certifiée ISO 13485.

Pixium Vision est coté sur Euronext (Compartiment C) à Paris.

ISIN: FR0011950641 ; Mnemo: PIX

  IRIS® est une marque déposée de Pixium-Vision SA

 

 

Avertissement :

 Le présent communiqué contient de manière implicite ou expresse certaines déclarations prospectives relatives à Pixium Vision et à son activité. Ces déclarations dépendent de certains risques connus ou non, d’incertitudes, ainsi que d’autres facteurs, qui pourraient conduire à ce que les résultats réels, les conditions financières, les performances ou réalisations de Pixium Vision diffèrent significativement des résultats, conditions financières, performances ou réalisations exprimés ou sous-entendus dans ces déclarations prospectives.

Pixium Vision émet ce communiqué à la présente date et ne s’engage pas à mettre à jour les déclarations prospectives qui y sont contenues, que ce soit par suite de nouvelles informations, événements futurs ou autres.

Pour une description des risques et incertitudes de nature à entraîner une différence entre les résultats réels, les conditions financières, les performances ou les réalisations de Pixium Vision et ceux contenus dans les déclarations prospectives, veuillez-vous référer au chapitre 4 « Facteurs de risques » du document de base de la Société enregistré auprès de l’Autorité des marchés financiers sous le numéro I. 14-030 le 12 mai 2014 et au  chapitre 2 « Facteurs de risques liés à l’Offre » de la note d’opération, lesquels peuvent être consultés sur les sites de l’Autorité des marchés – AMF (www.amf-france.org)) et de Pixium Vision (www.pixium-vision.com).

26/02/2015

LEIDEN, Netherlands, Feb. 26, 2015 – ProQR Therapeutics N.V. (Nasdaq:PRQR), a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe diseases such as cystic fibrosis and Leber’s congenital amaurosis, today announced results for the fourth quarter and full year 2014.

« In 2014, ProQR has made significant accomplishments on our path to develop life-changing therapies, » said Daniel de Boer, Chief Executive Officer of ProQR. « We have advanced QR-010 through preclinical development and are looking forward to starting the clinical development of this potentially disease modifying treatment for patients with cystic fibrosis. In parallel, we continued to build our platform and pipeline of proprietary programs, including advancing QR-110 towards clinical development for Leber’s Congenital Amaurosis (LCA), the leading genetic cause of blindness in childhood. We have successfully financed the Company through a private placement financing round and an Initial Public Offering (IPO) on the NASDAQ Global Market, funding our planned clinical development work to bring our programs closer to patients. »

Financial Highlights
Net cash generated by financing activities during the year ended December 31, 2014 was €119.9 million. This includes the net proceeds from our IPO in the third quarter of 2014 and the net proceeds from the private placement financing round in the second quarter of 2014, as well as proceeds from borrowings, representing receipts from our innovation credit from the Dutch government for our cystic fibrosis program. As of December 31, 2014, we held cash and cash equivalents of €112.7 million. Net cash used in operating activities during the three months and full year ended December 31, 2014 was €5.0 million and €14.5 million, respectively.
Research and development costs were €3.3 million for the three months ended December 31, 2014, compared to €1.3 million for the same period in 2013. Research and development costs for the year ended December 31, 2014 were €10.3 million, compared to €2.6 million for the same period in 2013. The increase reflects the expansion of research and development activities to support the further development of our lead product candidate, QR-010, for the treatment of cystic fibrosis in patients with the ∆F508 mutation, as well as the development of our other pipeline product candidates, including QR-110 for the treatment of LCA in patients with the most prevalent mutation in the CEP290 gene.
General and administrative costs were €2.0 million for the three months ended December 31, 2014, compared to €0.3 million for the same period in 2013. General and administrative costs for the year ended December 31, 2014 were €6.5 million, compared to €0.8 million for the same period in 2013. The increase reflects the preparatory costs associated with the Company’s IPO on the Nasdaq Global Market, a grant to ProQR’s protection foundation, and increased costs reflecting the Company’s growth.
Net loss for the three months ended December 31, 2014 was €2.0 million, or €0.09 per share, compared to €1.6 million, or €0.27 per share for the same period in 2013. Net loss for the year ended December 31, 2014 was €12.1 million, or €1.09 per share, compared to €3.3 million, or €0.59 per share for the same period in 2013. For further financial information for the periods ended December 31, 2014, please refer to the financial statements appearing at the end of this release.

FY2014 Corporate Highlights
• Advanced QR-010 through pre-clinical development and prepared for the initiation of our clinical studies.
• Advanced QR-110 through discovery and initiated preclinical development of this program for the treatment of treatment of LCA in patients with the most prevalent mutation in the CEP290 gene. LCA is the leading genetic cause of blindness in childhood.
• Continued to build our early stage discovery platform with a number of exciting programs that could add to our pipeline of product candidates to treat severe genetic disorders with very high unmet medical needs.
• Completed a private placement financing round, raising approximately €42 million of gross proceeds from high quality institutional investors.
• Entered into an agreement with Cystic Fibrosis Foundation Therapeutics, Inc. (« CFFT »), a subsidiary of the Cystic Fibrosis Foundation, pursuant to which CFFT agreed to provide us with up to $3 million to support the clinical development of QR-010. The Cystic Fibrosis Foundation is a professional patient advocacy organization that supports select CF drug development programs by providing financial support and access to its Therapeutic Development Network, a network of CF key opinion leaders, as well as to an extensive clinical trial network infrastructure.
• Successfully completed our initial public offering on NASDAQ Global Market in September 2014, placing 8,625,000 ordinary shares at a public offering price of $13.00 per share, which includes the exercise in full by the underwriters of their option to purchase 1,125,000 additional ordinary shares, resulting in aggregate net proceeds, after underwriting discounts and commissions and other estimated offering expenses, of approximately $102 million (€79.3 million).
• Entered into an agreement with PARI Pharma GmbH in October 2014, pursuant to which the Company is granted an exclusive license to the use of PARI’s eflow technology for the administration of oligonucleotide-based drugs in the ∆F508 mutation in cystic fibrosis, with the option to expand this exclusivity to the use in other CF mutations. Pursuant to the terms of the agreement, we have made an upfront payment, fees for development work and are obligated to make sales-based royalty payments after market authorization.
• Significantly strengthened our Management Team through the addition of Noreen Henig as Chief Development Officer and Smital Shah as Chief Financial Officer.
• Formally appointed our Supervisory Board, consisting of industry veterans and thought leaders that bring significant operational, international, regulatory and senior management experience within the pharmaceutical and biotechnology industries, including Dinko Valerio, Henri Termeer, Antoine Papiernik and Alison Lawton.

Subsequent Events
• Paul Baart was nominated to serve as a member of our Supervisory Board and the Chair of the Audit Committee, to be appointed at the 2015 Annual General Shareholders Meeting. Paul brings significant experience to the Supervisory Board and Audit Committee through his extensive career in public accounting in both the Netherlands and the USA. At PwC Netherlands he served on the Management and Supervisory Boards and was also a member of the Global Board of PwC International. While at PwC, Paul’s clients included several large private and public multinational companies across a variety of industries. His qualifications include being chairman of Royal NIVRA, the Dutch Institute of Registered Accountants (now NBA), member of the Dutch Council on Annual Reporting (RJ), Supervisory Board member of Nyenrode Business University, outside member of the Enterprise Chamber Amsterdam Court of Appeal (Ondernemingskamer), member of the Board of Central Housing Fund (CFV) and Chairman of the public interest committee at Grant Thornton in the Netherlands. He studied Business Economics at the Vrije Universiteit in Amsterdam, where he also passed the Register accountants exam. We believe that Paul’s significant international experience in public accounting and his broad experience in management, oversight and boardroom consulting provide him with the qualifications and skills to be a very valuable addition to our Supervisory Board.
2014 Annual Reports
ProQR Therapeutics N.V. will publish its 2014 Annual Report on Form 20-F, Statutory Annual Report, and Compensation Report in Q2 2015. The reports will be published on our website at www.proqr.com

About ProQR
ProQR Therapeutics is dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe diseases such as cystic fibrosis and Leber’s congenital amaurosis. Based on our unique proprietary RNA repair platform technologies we are growing our pipeline with patients and loved ones in mind. Since 2012.

FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as « anticipate, » « believe, » « could, » « estimate, » « expect, » « goal, » « intend, » « look forward to », « may, » « plan, » « potential, » « predict, » « project, » « should, » « will, » « would » and similar expressions. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, statements regarding the clinical development of QR-010, our ongoing and planned discovery and development of product candidates, effects of additions to our management team and Supervisory Board, our agreement with CFFT and PARI Pharma GmbH. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with our clinical development activities, manufacturing processes and facilities, regulatory oversight, product commercialization, intellectual property claims, and the risks, uncertainties and other factors described under the heading « Risk Factors » in ProQR’s prospectus filed with the Securities and Exchange Commission dated September 19, 2014. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.

ProQR Therapeutics N.V.:
Smital Shah
Chief Financial Officer
T: +1 650 464 9879
ir@proqr.com
Media inquiries:
Gretchen Schweitzer
MacDougall Biomedical Communications
Direct: +49 172 861 8540
Main: +49 89 2424 3494

26/02/2015

Collaboration entails development of gene therapy treatment for severe neurodegenerative disease GM1-gangliosidosis

Paris, France—February 10, 2015— LYSOGENE, a leading, clinical stage gene therapy biotechnology company committed to the development and commercialization of breakthrough treatments for severe orphan pathologies affecting the central nervous system (CNS), today announced that it has entered into a strategic collaboration with the University of Massachusetts Medical School (UMMS) in Worcester, Massachusetts, and Auburn University (AU) in Auburn, Alabama. Through the collaboration, LYSOGENE, UMMS and AU will develop IND-supporting preclinical studies in GM1-gangliosidosis, a rare, inherited disorder characterized by severe neurological impairment, using adeno-associated virus (AAV) gene therapy technology.

The collaboration will combine LYSOGENE’s outstanding translational and clinical expertise in gene therapy for CNS disorders with the unique preclinical expertise and infrastructure of UMMS and AU to design and test innovative AAV-based gene therapy approaches to treat GM1-gangliosidosis.

The development of a potential treatment for GM1-gangliosidosis using AAV gene therapy was initiated in 2005 by Miguel Sena-Esteves, PhD, associate professor in the Neurology Department and the Gene Therapy Center at UMMS, and Douglas R. Martin, PhD, associate professor in the Scott-Ritchey Research Center and Department of Anatomy, Physiology & Pharmacology at AU. The approach developed by the investigators uses AAV vectors to treat the entire brain and spinal cord after injection of only a few intracranial sites. Preclinical studies demonstrated a remarkable extension in lifespan from 8 months in untreated GM1 cats to greater than 4.5 years in AAV-treated cats, with dramatic improvements in quality of life. Results were published in Science Translational Medicine in 2014 (McCurdy, V.J., et al., Sustained normalization of neurological disease after intracranial gene therapy in a feline model. Science Translational Medicine, 2014. 6(231): p. 231ra48).

“We are thrilled by our collaboration with University of Massachusetts Medical School and Auburn University, which constitutes a significant step towards the development of a treatment for patients affected with GM1-gangliosidosis, a severely debilitating disease. For each of these patients and their families, there is currently no option and an urgent need for a safe and effective therapy”, said Karen Aiach, founding president and CEO of LYSOGENE. “AAV-based therapies are particularly suitable for inherited disorders of the CNS. In this new program, LYSOGENE will leverage its unique capacity to develop these therapies and bring them to patients with unmet needs. We will also reinforce our scientific and technology base through our collaboration with leaders in the field.”

“Collaborating with LYSOGENE will allow us to leverage their clinical and translational expertise and advance the development of a gene transfer therapy for treating patients affected with GM1-gangliosidosis,” said Sena-Esteves. “In our minds, what ultimately matters is the ability to deliver a potential treatment to the children suffering from this horrible disease. Ultimately, that’s what drives us all.”

About Gangliosidosis with GM1
GM1-gangliosidosis is a rare inherited neurodegenerative disorder characterized by severe cognitive and motor developmental delays resulting in death of most patients at a very young age.

It is caused by mutations in the GLB1 gene, which encodes an enzyme called beta-galactosidase necessary for recycling of a molecule (GM1-ganglioside) in neurons. This brain lipid is indispensable for normal function, but its overabundance causes neurodegeneration, resulting in the severe neurological symptoms of GM1-gangliosidosis.

GM1 affects 1 in 100,000 – 200,000 newborns and is inherited in an autosomal recessive pattern. GM1-gangliosidosis can be classified into three major clinical phenotypes according to the age of onset and severity of symptoms: Type I (infantile), Type II (late infantile/juvenile) and Type III (adult). There is currently no treatment for this disease.

About LYSOGENE
LYSOGENE is a clinical stage biotechnology company committed to the development and commercialization of innovative therapies for patients affected with rare disorders and high unmet medical needs. LYSOGENE’s team translated its rAAVrh10 lead product for Sanfilippo from bench to bedside in an unprecedented fashion over the last years. Its lead product is for Sanfilippo syndrome, a neurodegenerative lysosomal storage disorder considered to be a perfect model for gene therapy. LYSOGENE is currently expanding its pipeline to additional diseases with high unmet medical needs. Lysogene was launched in 2009. It completed a Series A financing in May 2014 with leading life sciences investors Sofinnova Partners, BPI Innobio and Novo AIS.

For more information about LYSOGENE, please visit www.lysogene.com

About University of Massachusetts Medical School
The University of Massachusetts Medical School (UMMS), one of five campuses of the University system, is comprised of the School of Medicine, the Graduate School of Biomedical Sciences, the Graduate School of Nursing, a thriving research enterprise and an innovative public service initiative, Commonwealth Medicine. Its mission is to advance the health of the people of the Commonwealth through pioneering education, research, public service and health care delivery with its clinical partner, UMass Memorial Health Care. In doing so, it has built a reputation as a world-class research institution and as a leader in primary care education. The Medical School attracts more than $240 million annually in research funding, placing it among the top 50 medical schools in the nation. In 2006, UMMS’s Craig C. Mello, PhD, Howard Hughes Medical Institute Investigator and the Blais University Chair in Molecular Medicine, was awarded the Nobel Prize in Physiology or Medicine, along with colleague Andrew Z. Fire, PhD, of Stanford University, for their discoveries related to RNA interference (RNAi). The 2013 opening of the Albert Sherman Center ushered in a new era of biomedical research and education on campus. Designed to maximize collaboration across fields, the Sherman Center is home to scientists pursuing novel research in emerging scientific fields with the goal of translating new discoveries into innovative therapies for human diseases.

About Auburn University and the College of Veterinary Medicine
Auburn University has provided instruction, research and outreach to benefit the state of Alabama and the nation for more than 155 years and is among a distinctive group of universities designated as Land, Sea and Space Grant institutions. Auburn makes a nearly $5 billion economic contribution to the state each year, has more than 250,000 graduates and provides 140 degree programs to more than 25,000 graduate and undergraduate students. For more news about Auburn University, go to www.auburn.edu. The College of Veterinary Medicine, the oldest veterinary medical program in the South, has a mission to prepare individuals for careers of excellence in veterinary medicine, including private and public practice, industrial medicine, academics, and research. The College is devoted to three strategic goals: (1) enhance student success; (2) promote discovery; and (3) practice the highest standards of veterinary medicine. For more, go to www.vetmed.auburn.edu. The Scott-Ritchey Research Center’s mission is to improve the health of companion animals and translate those findings to the clinical and scientific communities to facilitate their application in humans.

For more information, please contact:

Marion Janic
Rooney & Associates
mjanic@rooneyco.com
+1 (212) 223-4017

25/02/2015

Company moves toward first commercial cellulosic glucose facility
London, Ontario, Canada, February 25, 2015 ‐ Comet Biorefining Inc., a leader in high-quality cost-competitive cellulosic glucose technology announces the closing of a funding round led by Sofinnova Partners. Comet will use the proceeds to complete the design of its commercial facility, expand the team and continue to develop commercial partnerships.

Comet has developed a proprietary technology for the conversion of wood, wheat straw, bagasse, corn stover and similar agricultural wastes into high purity glucose syrup. Due to its high yield and short production times the process allows for smaller facilities closer to biomass sources with lower overall production costs. Comet has proven the technology at 5 dry tons per day demonstration scale and is well positioned for commercial scale.
“We are extremely pleased to welcome Sofinnova Partners as our investor”, commented Dr. Andrew Richard, Comet Founder and Chief Technology Officer, “They bring extensive experience, a proven track record, and a vast network of contacts in the renewables industry. Their support will help accelerate the commercialization of Comet’s cellulosic glucose technology.”
“Comet brings a paradigm shift to the cellulosic glucose market”, stated Joško Bobanović, new Comet director and Sofinnova Green Seed Fund Partner,” This scaled up, unique and robust technology enables production of cost competitive high-quality cellulosic glucose thus enabling many players to switch in the near term to non-food renewable feedstocks while improving margins.”
Comet plans its first commercial demonstration facility at 100 dry tons of glucose syrup per day capacity and is actively developing upstream and downstream commercial partnerships. The use of sustainable non-food sources allows for lower overall cost and price stability when compared to food sugars coming from corn or sugar cane. The high quality of the glucose enables applications in bio-based chemicals as well as biofuels.

About Comet Biorefining Inc.
Comet Biorefining is a leading provider of sustainable high-quality cost-competitive cellulosic glucose technology for applications in renewable biofuels and biochemicals. The company’s proprietary technology allows for the conversion of wood, wheat straw, bagasse, corn stover and other agricultural waste materials into high purity cellulosic glucose syrup. These non-food sources offer lower cost and price stability when compared to food sugar sources such as corn or sugar cane. Demonstrated at 5 dry tons per day scale, Comet is focusing on commercial scale up and development of commercial partnerships with applications in renewables industries. www.cometbiorefining.com

About Sofinnova Partners
Sofinnova Partners is an independent venture capital firm based in Paris, France. For more than 40 years, the firm has backed nearly 500 companies at different stages of their development – pure creations, spin-offs, as well as turnaround situations – and worked alongside Europe’s key entrepreneurs in the Life Sciences industry. With €1.3 billion of funds under management, Sofinnova Partners has created market leaders with its experienced team and hands-on approach in building portfolio companies through to exit. www.sofinnova.fr
For further information:
Andrew Richard, PhD
CTO and Founder
Comet Biorefining Inc.
700 Collip Circle, Suite 211
London, Ontario, CANADA N6G 4X8
(519) 494‐7514 info@cometbiorefining.com

11/02/2015

Avec la vente de GlycoVaxyn, Sofinnova Partners réalise sa 14ème sortie/IPO en 24 mois pour une valeur d’entreprise totale de 3,4 milliards de dollars

Paris, France – 11 février 2015. Sofinnova Partners, société de capital-risque basée à Paris, annonce la vente de GlycoVaxyn, une société de son portefeuille spécialisée dans le développement de vaccins conjugués innovants, à GlaxoSmithKline pour un montant 212 M$. Investisseur depuis l’amorçage en 2006, Sofinnova Partners a activement soutenu la croissance ultérieure de GlycoVaxyn et demeuré le principal actionnaire jusqu’à aujourd’hui.

Spécialisée dans le développement de la prochaine génération de vaccins conjugués, GlycoVaxyn a créé une plateforme révolutionnaire de bio-conjugaison qui permet de produire des vaccins conjugués grâce à un procédé biologique qui évite les nombreux inconvénients associés aux méthodes chimiques utilisées à ce jour. Cette plateforme propriétaire permet de développer des vaccins complexes multivalents de façon plus simple, plus rapide et plus fiable. Utilisés depuis plus de quarante ans pour lutter contre les infections bactériennes, comme la méningite et la pneumonie, les vaccins conjugués représentent actuellement près de 30% des ventes de vaccins annuelles dans le monde.
Depuis l’amorçage autour de Michael Waker, le fondateur et Directeur scientifique, Sofinnova Partners a joué un rôle déterminant pour accélérer la croissance de GlycoVaxyn, mettant à profit son réseau financier et industriel. Au cours des ans, Sofinnova Partners a continué à financer la société, facilité son accès à d’autres investisseurs de premier plan, consolidé sa direction grâce au recrutement de Philippe Dro, PDG de GlycoVaxyn et précédemment PDG de Endoart, une société financée par Sofinnova Partners et cédée à Allergan en 2005, de Gerd Zettlmeissl, Président de GlycoVaxyn et précédemment PDG d’Intercell, et de Paul-Henri Lambert, Président du Conseil Scientifique de GlycoVaxyn. Actuellement, GlycoVaxyn emploie 50 salariés, dispose de cinq produits en développement, et deux partenariats scientifiques majeurs avec Janssen Pharmaceuticals et GlaxoSmithKline.
Graziano Seghezzi, Partenaire chez Sofinnova Partners et membre du Conseil de surveillance de GlycaVaxyn, déclare : « soutenir des scientifiques et entrepreneurs visionnaires autour d’une technologie de rupture bénéficiant d’une solide propriété intellectuelle est au coeur de la stratégie de Sofinnova Partners ; et c’est exactement ce que nous avons accompli avec GycoVaxyn. En tant qu’investisseur ‘early stage’, nous mobilisons nos ressources financières et notre réseau pour aider les entrepreneurs à développer au maximum leur entreprise ».
Philippe Dro, PDG de GlycoVaxyn, poursuit : « investisseur historique de GlycoVaxyn, Sofinnova Partners a pleinement joué son rôle de capital-risqueur avec une vision long terme. De l’amorçage jusqu’à aujourd’hui, il est resté l’actionnaire le plus important, et de façon active a contribué à notre croissance ».
Avec la vente de Glycovaxyn, Sofinnova Partners réalise la 14ème sortie/IPO en 24 mois d’une société de son portefeuille, pour une valeur d’entreprise totale de 3,4 milliards de dollars. Au cours des cinq dernières années, Sofinnova Partners a généré des sorties et des introductions en bourse pour une valeur d’entreprise qui totalise 6,5 milliards de dollars, avec des cessions industrielles comme Omthera Pharmaceuticals cédée à AZ ou EOS à Clovis Oncology, et des introductions en bourse sur le Nasdaq, comme celle de DBV Technologies (DBVT) ou Ascendis Pharma (ASND).

A propos de Sofinnova Partners
Sofinnova Partners est une société de capital-risque indépendante basée à Paris. Depuis plus de 40 ans, la société a financé près de 500 sociétés – start-up, spin-off et opérations de retournement. Elle a accompagné les plus grands entrepreneurs européens dans le domaine des sciences de la vie. Avec 1,3 milliard d’euros sous gestion, l’équipe de Sofinnova Partners, reconnue pour sa capacité à aider et à soutenir les entreprises de son portefeuille de la création à la sortie, a permis l’émergence de leaders sur leurs marchés. Pour en savoir plus, consultez www.sofinnova.fr

Pour plus d’information sur GlycoVaxyn, veuillez consulter le site de la société : www.glycovaxyn.com

03/02/2015

Copenhagen, Denmark, February 2, 2015 ‐ Ascendis Pharma A/S (Nasdaq: ASND), a clinical stage biopharmaceutical company, today announced the closing of its initial public offering of 6,900,000 American Depositary Shares (ADSs) at a price to the public of $18.00 per ADS, which includes the exercise in full by the underwriters of their option to purchase additional ADSs. Ascendis estimates net proceeds from the offering to be approximately $111.5 million, after deducting underwriting commissions and estimated offering expenses.

BofA Merrill Lynch and Leerink Partners LLC acted as joint book‐running managers for the offering. Wells Fargo Securities acted as co‐manager.

The offering was made solely by means of a prospectus, copies of which may be obtained by contacting BofA Merrill Lynch, 222 Broadway, New York, NY 10038, Attn: Prospectus Department, or by email at dg.Prospectus_Requests@baml.com; or Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by email at syndicate@leerink.com, or by phone at (800) 808‐7525.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on January 27, 2015. Copies of the registration statement, as amended, can be accessed through the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Ascendis Pharma A/S
Ascendis Pharma A/S is a clinical stage biopharmaceutical company applying its TransCon technology to develop a pipeline of long‐acting prodrug therapies with best‐in‐class profiles to address large markets with significant unmet medical needs.

Contact:
Investor Contact:
Martin Auster, M.D.
Chief Business Officer
(650) 617‐3403
ir@ascendispharma.com

Media Contact:
Marion Janic
Rooney & Associates
(212) 223‐4017
mjanic@rooneyco.com